EUCTR2009-015780-14-AT
Active, not recruiting
Not Applicable
The effect of high dose remifentanil on the reversal of established sunburn-induced hyperalgesia in human volunteers - High-Dose-RemiSun
Abteilung für Anästhesie und Intensivmedizin, Medizinische Universität Wien0 sitesNovember 12, 2009
DrugsUltiva
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Volunteer study with 24 healthy volunteers to perform pain research and to study the reversal of hyperalgesia by IMP
- Sponsor
- Abteilung für Anästhesie und Intensivmedizin, Medizinische Universität Wien
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women, aged between 19 and 40 years
- •Body mass index between 15th and 85th percentile
- •Normal findings in the medical history and physical examination
- •Drug free for 1 week prior to the study day
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Regular use of medication especially analgesics
- •Abuse of alcoholic beverages, drug abuse
- •History of asthma
- •Participation in a clinical trial in the 2 weeks preceding the study
- •Symptoms of a clinically relevant illness in the 2 weeks before the first study day
- •Resting systolic blood pressure \>135mmHg or diastolic blood pressure \>85mmHg
- •History of allergy to any of the medications used in the study
- •Pregnancy or breast feeding
- •Acute skin diseases like sunburn or skin lesions on the relevant areas and UV sensitive skin conditions, like Xeroderma pigmentosa
Outcomes
Primary Outcomes
Not specified
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